FDA 510(k)

EndoLIF Delta-Cage 及 DoubleWedge-Cage

K 號：K203014 · 2021-09-01

決定日期2021-09-01

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

EndoLIF Delta-Cage and DoubleWedge-Cage is the device name listed in this FDA 510(k) record. The listed applicant is Joimax GmbH. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K203014. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoLIF Delta-Cage and DoubleWedge-Cage?

EndoLIF Delta-Cage and DoubleWedge-Cage is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Joimax GmbH. The 510(k) number is K203014.

When did EndoLIF Delta-Cage and DoubleWedge-Cage receive FDA 510(k) clearance?

EndoLIF Delta-Cage and DoubleWedge-Cage received FDA 510(k) clearance on 2021-09-01, under 510(k) number K203014.

Who is the listed applicant for EndoLIF Delta-Cage and DoubleWedge-Cage?

The FDA 510(k) record lists Joimax GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoLIF Delta-Cage and DoubleWedge-Cage?

The FDA product code for EndoLIF Delta-Cage and DoubleWedge-Cage is MAX.

其他以 Joimax GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MAX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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